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NCT Number: NCT07356648

Diadynamic Current and Carpal Tunnel Syndrome

Carpal tunnel syndrome (CTS), first described by Paget in 1854, is the most common entrapment neuropathy. Conservative treatment approaches are prioritized in patients with mild to moderate CTS. Conservative management includes education, tendon and median nerve gliding exercises, physical therapy modalities, kinesiotaping, manual therapy techniques, injection options, and oral medical treatments. First-line treatment generally consists of education, exercise, and splinting.

Tendon and median nerve gliding exercises represent key components of conservative treatment. Splinting is recommended at all stages of CTS, with wrist splints designed to maintain a neutral position being the most commonly preferred option. The prevailing approach in the literature supports the use of splints primarily during nighttime.

Diadynamic current (DDC) is considered to have a composite analgesic mechanism, primarily explained by the gate control theory. Additional mechanisms suggest that DDC affects both sensory and motor nerves and may increase endorphin release, contributing to pain relief. A single treatment session typically does not exceed 12 minutes. Some studies indicate that the analgesic effect of DDC may be greater than that of transcutaneous electrical nerve stimulation (TENS). Although TENS is widely used in physical therapy and rehabilitation practice, DDC may represent a realistic alternative for clinical pain management.

The aim of the study is to evaluate the effect of diadynamic current therapy on clinical symptoms in patients with CTS and to investigate its impact on electrophysiological findings of the median nerve.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Carpal Tunnel Syndrome (CTS) Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Sprains and Strains Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Düzce University

Düzce, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinically and electrophysiologically diagnosed with carpal tunnel syndrome (CTS)
  • Provision of informed consent
  • Age between 18 and 65 years

Exclusion criteria

  • Age below 18 years or above 65 years
  • Median nerve distal motor latency > 6.0 ms on nerve conduction studies (NCS)
  • Thenar muscle atrophy
  • History of carpal tunnel syndrome surgery
  • History of steroid injection into the carpal tunnel
  • History of physical therapy for CTS within the past 6 months
  • Cervical radiculopathy
  • Tenosynovitis in the ipsilateral upper extremity
  • Other compressive neuropathy in the ipsilateral upper extremity
  • Peripheral polyneuropathy
  • History of trauma or fracture involving the hand, wrist, or forearm
  • Pregnancy
  • Presence of metabolic disease
  • Inflammatory rheumatic disease
  • Acute and/or chronic renal failure
  • Severe cognitive impairment preventing understanding and following simple instructions
  • Severe visual or hearing impairment preventing participation in treatment
  • Current use of pregabalin or gabapentin
  • Systemic diseases (e.g., diabetes mellitus, hypothyroidism, rheumatic diseases)

Treatment and study plan

Diadynamic Current

Procedure

Diadynamic current (DDC) is a routine therapeutic modality applied in the physical medicine and rehabilitation clinic to alleviate symptoms in various conditions. In individuals with carpal tunnel syndrome (CTS), DDC is routinely administered in cases where sufficient benefit is not achieved with splinting and transcutaneous electrical nerve stimulation (TENS).

For this purpose, diadynamic current is applied to the palmar surface of the hand and the volar surface of the forearm using equal-sized carbon electrodes (6 × 6 cm). A sequence of different types of diadynamic currents is administered for a total duration of 10 minutes as follows: diphase fixe (DF) for 2 minutes, monophase fixe (MF) for 3 minutes, longues périodes (LP) for 3 minutes, and courtes périodes (CP) for 2 minutes.

The treatment duration, parameters, and sequence of diadynamic currents are based on Bernard's current methodology and are identical to the procedure described by Ratajczak et al.

Wrist Splint

Procedure

In individuals with carpal tunnel syndrome, splinting is routinely prescribed as a first-line conservative treatment. A resting wrist splint extending from the distal forearm to the hand and maintaining the wrist in a neutral position is provided to both groups. The splint is worn every night before bedtime, maintained throughout the night, and removed in the morning upon waking.

Primary outcomes

  1. Change from Baseline in Boston Carpal Tunnel Questionnaire Symptom Severity Scale Score

    Time frame: Baseline and 6 weeks

    Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS) is a patient-reported outcome measure assessing symptom severity in individuals with carpal tunnel syndrome. Scores range from 1 to 5, with higher scores indicating worse symptom severity.

  2. Change from Baseline in Boston Carpal Tunnel Questionnaire Functional Status Scale Score

    Time frame: Baseline and 6 weeks

    Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS) assesses functional status and difficulty in daily activities in individuals with carpal tunnel syndrome. Scores range from 1 to 5, with higher scores indicating worse functional status.

  3. Change from Baseline in Hand Grip Strength (kg)

    Time frame: Baseline and 6 weeks

    Hand Grip Strength was measured using a Saehan SH5001 Hydraulic Hand Dynamometer and recorded in kg. Higher values indicate greater grip strength.

  4. Change from Baseline in Pinch Grip Strength (kg)

    Time frame: Baseline and 6 weeks

    Pinch Grip Strength was measured using a Saehan SH5005-1 Mechanical Pinch Gauge and recorded in kg. Higher values indicate greater pinch strength.

  5. Electrophysiological Assessment-Median Distal Motor Latency

    Time frame: Baseline and 6 weeks

    Median distal motor latency was evaluated using nerve conduction studies (NCS) performed at the Electromyography Laboratory of the Department of Neurology, Düzce University Faculty of Medicine. Measurements were recorded in milliseconds (ms).

    Electrophysiological carpal tunnel syndrome was defined as median distal motor latency ≥ 4.0 ms.

  6. Electrophysiological Assessment- Median Sensory Nerve Conduction Velocity

    Time frame: Baseline and 6 weeks

    Median sensory nerve conduction velocity was evaluated using nerve conduction studies (NCS) performed at the Electromyography Laboratory of the Department of Neurology, Düzce University Faculty of Medicine. Measurements were recorded in meters per second (m/s).

    Electrophysiological carpal tunnel syndrome was defined as median sensory nerve conduction velocity ≤ 40 m/s.

  7. Electrophysiological Assessment-Median-Ulnar Sensory Peak Latency Difference

    Time frame: Baseline and 6 weeks

    Comparative median-ulnar sensory peak latency analysis was performed using fourth-digit recordings with wrist stimulation during nerve conduction studies (NCS). Measurements were recorded in milliseconds (ms).

    Electrophysiological carpal tunnel syndrome was defined as median sensory peak latency from the fourth digit exceeding ulnar latency by ≥ 0.4 ms.

Sponsors and collaborators

Lead sponsor

Duzce University

Other

Registry information

Official study title

Investigation of the Effectiveness of Diadynamic Current in Patients With Carpal Tunnel Syndrome

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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